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OpenTrials
Completed

NCT Number: NCT03192553

Alternative Doffing Strategies to Prevent Healthcare Worker Self-Contamination When Using Personal Protective Equipment (PPE)

Alternative doffing strategies may help prevent self-contamination of staff members when using PPE. The study aims to determine which among the suggested methods in the literature that have been proposed as alternatives to the traditional CDC recommended doffing protocol, would be most beneficial to reduce healthcare worker self-contamination.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

A randomized controlled trial of doffing procedures will be conducted by healthcare worker volunteers who participate in direct patient care. However, doffing simulations will be conducted outside of patient care areas and will not involve patients. Staff participants PPE techniques will be evaluated in the controlled environment of the simulation center of the Unique Pathogens Unit. The comparison groups will be the Centers for Disease Control (CDC) procedure with the addition of a second layer of gloves (double gloving procedure), the CDC procedure with additional hand hygiene performed on gloves at key steps (intensified hand hygiene procedure), and the one-step roll off of gown and gloves (one-step procedure), with the CDC procedure as the control. Participants will be assigned to a doffing protocol chronologically starting with the double glove and ending with the control until 100 volunteers have participated. Additional PPE such as masks and goggles will be removed as part of each of the four protocols. Healthcare workers will receive a demonstration of the donning/doffing from the study coordinator, and perform a practice donn/doff prior to the observed simulation. Only one volunteer with participate in each simulation session. Glogerm (TM) will be applied to PPE in a thin stripe and smoothed to evenly with gloved hands to cover arms, trunk, and gown hem. S. epidermidis will be applied using colonies diluted in solution and spread over gloves, arms, trunk, hem with a swab.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical Providers at VCU Medical Center, including medical degree holding trainees who are medical housestaff Adults > or =18 years of age

Exclusion criteria

students pregnant or breastfeeding healthcare workers non-clinical providers children/teens <18 years of age open skin lesions or dermatitis presence of prosthetic materials such as prosthetic joints, heart valves

Treatment and study plan

Double Gloving Procedure

Behavioral

Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Intensified Hand Hygiene Procedure

Behavioral

Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

One Step Procedure

Behavioral

Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

CDC Procedure

Behavioral

Participants will doff PPE using a CDC recommended procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis

Primary outcomes

  1. Self-contamination rate

    Time frame: Assessed immediately after each post-doffing simulation - self-contamination will be documented during the simulation appointment, immediately following doffing, by visual assessment

    Measure of frequency of contamination by body site for each doffing procedure via visual assessment

Secondary outcomes

  1. Acceptability of doffing procedure to healthcare workers

    Time frame: Assessed immediately after each post-doffing simulation - the questionnaire will be administered before the participant leaves the simulation appointment

    Aspects of acceptability such as ease, comfort, and efficacy measured by Likert Scale Staff Questionnaire (1=strongly disagree, 5=strongly agree

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2017
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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